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NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.

NEOLab Clear Aligners consist of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane-polyester resin, and are intended to be worn 22 hours a day. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.

The provided document (K203339) is a Special 510(k) summary for the NEOLab Clear Aligners. It focuses on demonstrating substantial equivalence to a predicate device (Ormco Spark Aligner System, K182826) by showing that the new device has the same intended use, similar technological characteristics, and meets material and manufacturing specifications.

However, this document does NOT describe the acceptance criteria and the study that proves a device (e.g., an AI-powered device or a diagnostic device) meets specific performance criteria through a clinical or algorithmic performance study.

The testing described in this document is primarily related to:

• Mechanical properties of the aligner material: Ensuring it meets specifications for shelf life.
• Validation of manufacturing processes: Confirming the custom aligner fabrication.
• Biocompatibility testing: According to ISO 10993 standards for the thermoplastic polyurethane-polyester resin and the finished aligner.

There is no mention of a study involving:

• A test set of data (e.g., medical images, patient records).
• Any form of algorithm performance evaluation (e.g., accuracy, sensitivity, specificity, AUC).
• Human expert readers establishing ground truth.
• Multi-reader multi-case (MRMC) studies.
• Effect sizes of human reader improvement with AI assistance.
• Stand-alone algorithm performance.

Therefore, I cannot populate the requested table and information based on the provided text, as the document does not contain the study details you are asking for.

The document states:

• "Test data were submitted to: Assure the aligner mechanical properties of the aligner material meet specifications for up to 5 years shelf life; Validate the processes used for the design and manufacture of the customized aligners."
• "Biocompatibility: The thermoplastic polyurethane-polyester resin used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993..."
• "This testing showed that the material and manufactured aligner met the acceptance criteria, passed the respective tests, and are safe and biocompatible for the stated intended use."

This indicates that acceptance criteria existed for the material properties and biocompatibility, but these are not performance metrics for a diagnostic or AI device that interacts with patient data in the way implied by your questions about ground truth, expert readers, and test sets.

To fulfill your request, the document would need to describe a study evaluating the performance of a device, for example, an AI algorithm that analyzes orthodontic scans, or a diagnostic tool. Since this is a 510(k) for physical clear aligners, the type of performance evaluation differs significantly.

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NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.

NEOLAB Clear Aligners consist of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.

The aligners, customized for each patient's prescription, are designed and manufactured based on either standard impressions or intraoral scans taken by the dental clinician and which are then sent to the company. The aligners are then sent back to the dental clinician who then distributes them in sequential stages to the patient and follows up with the patient through orthodontic examinations to check device fit and function.

During manufacturing, models are made from physical impressions or intraoral scans. Those made from stone or plaster impressions are scanned into the computer and made into digital files. The intraoral scans arrive as digital files. The digital files are 3D printed and are used to produce the aligner series with the thermoplastic polyurethane.

The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, including the predicate aligners.

The NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition by positioning teeth through the use of continuous gentle force.

Here's an analysis of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• The document primarily describes laboratory and bench testing of the device material and manufacturing process and biocompatibility testing.
• There is no mention of a "test set" in the context of patient data or clinical performance evaluation for the NEOLab Clear Aligners.
• The comparison to the predicate device (ClearCorrect System) is based on technological characteristics and indications for use, not on specific clinical performance data from a test set.
• Data provenance: Not applicable as no clinical test set data is described. The performed tests are laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. The provided document does not describe a clinical study with a test set requiring expert ground truth establishment for diagnostic or treatment efficacy. The testing performed is focused on material properties, manufacturing validation, and biocompatibility.

4. Adjudication method for the test set

• Not applicable. No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a physical medical device (clear aligners), not an AI-powered diagnostic or assistive tool for human readers. There is no AI component or human reader interaction described that would necessitate an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm or software device that would have standalone performance. It is a physical aligner system. While software is used for planning and manufacturing, its performance is not assessed in "standalone" mode in the context of patient outcomes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the described tests:
  • Mechanical properties: The ground truth is established by the specified ASTM D638 standard and internal specifications for tensile strength, elongation, etc.
  • Biocompatibility: The ground truth is established by the ISO 10993 series of standards for biological evaluation of medical devices.
  • Manufacturing process validation: The ground truth would be the design specifications and expected output consistency of the aligners.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device that requires training data. The device's manufacturing process may involve internal process controls and validation using samples, but these are not referred to as a "training set" in the context of AI.

9. How the ground truth for the training set was established

• Not applicable, as no training set is described for this device.

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